LONDON — An experimental human papillomavirus vaccine made by Merck could offer a boost to the vaccine market, but the company will have to use effective marketing efforts to ensure uptake, according to a new study.

The London-based research and consulting firm GlobalData said Merck’s V503 vaccine, currently in phase-3 clinical trials, had strong potential because it protects against five HPV types not covered by current vaccines and demonstrates 97% efficacy against precancerous lesions caused by the additional virus types it contains.

"The introduction of a new vaccine offers an opportunity to rejuvenate the HPV vaccines marketplace, which is currently inhabited by Merck’s quadrivalent vaccine, Gardasil, and GSK’s bivalent offering, Cervarix," GlobalData infectious disease analyst Robert Wilson said. "However, a number of challenges remain within the marketplace. These need to be overcome to allow V503 to realize its full potential, and the vaccine itself may be part of the solution."

GlobalData said that uptake of Gardasil among eligible girls in the United States has stagnated at about 50% despite marketing by Merck, as well as marketing by GSK of Cervarix, due to a general lack of awareness of HPV and the benefits of vaccines for the infection.

NEW YORK — New cardiovascular health guidelines released this week could dampen the potential popularity of an up-and-coming class of cholesterol drugs, according to published reports.

Wall Street analysts, cited in news reports, said that the new American Heart Association and American College of Cardiology guidelines could result in lower uptake of an as-yet unapproved class of biologics known as PCSK9 inhibitors because they no longer establish specific cholesterol level targets as a goal and recommend broader use of statins, most of which are now available as generics, to reduce high-cholesterol risk.

One of the PCSK9 inhibitors is SAR236553/REGN727 (alirocumab), under development by Sanofi and Regeneron and currently in phase-3 clinical trials. The drugs work by targeting proprotein convertase subtilisin-kexin type 9, hence the name of the class. According to clinical trial results announced last month, alirocumab showed a significantly greater reduction in low-density lipoprotein "bad" cholesterol than ezetimibe, which Merck sells under the brand name Zetia.

LONDON — The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

GW Pharmaceuticals said Friday that the FDA had granted the designation to Epidiolex for Dravet syndrome, a severe, drug-resistant form of epilepsy that begins in infancy. The drug is an oral liquid of a highly purified extract of cannabidiol, a non-psychoactive molecule derived from the cannabis plant.

The FDA grants orphan drug designation to experimental treatments for diseases that affect fewer than 200,000 people in the United States. The agency has given physicians permission to use the drug to treat 125 children with Dravet syndrome. The disease affects about 5,440 people in the United States and causes lifelong, ongoing seizures and intellectual disability.

RELATED NEWS

The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths.
The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.

Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform.
Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.

This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6.
Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.
Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

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